RecruitingNCT05321459

Predictive Outcome in Comatose Patients

New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

100 participants

Start Date

Nov 15, 2023

Study Type

OBSERVATIONAL

Conditions

Cardiopulmonary Resuscitation coma Heart Arrest

Summary

Evaluating the prognosis of comatose patients after cardiac arrest (CA) in the intensive care unit (ICU) remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations, (among them auditive evoked potentials or AEP) but none has a sufficient sensitivity/specificity. In a preliminary study, the investigators developed an algorithm from the signal collected with AEP, and generated a probability map to visually classify the participants after the algorithm processing. Participants could be classified either with a good neurological prognosis or with bad neurological prognosis or death. The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of patients admitted to intensive care for coma in the aftermath of CA will predict neurological prognosis at 3 months with high sensitivity and specificity.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study aims to improve predictions of brain recovery in patients who remain in a coma after a cardiac arrest (when the heart stops). Researchers will use specialized brain monitoring tests (such as auditory evoked potentials) in the days after a cardiac arrest to identify signals that predict whether the patient is likely to wake up. You may be eligible if... - You are 18 or older - You are covered by French healthcare insurance - You were admitted to the intensive care unit following a cardiac arrest (whether outside or inside the hospital) - You remain in a coma on day 3 after the cardiac arrest You may NOT be eligible if... - The medical team has decided to limit life-sustaining treatments - You cannot have auditory evoked potential testing done (e.g., due to deafness or a condition blocking recording) - Your trusted person or you yourself (once awake) objects to participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNeurological prognosis

In usual practice, in intensive care unit, evaluating the neurological prognosis of comatose patients after cardiac arrest requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations (among them auditive evoked potentials or AEP). An algorithm (PRECOM tool) which has been previously developed from the signal extracted from AEP allows to visually classify the patients after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". The AEP signals recorded in the 1st and 2nd week of patient inclusion are to be collected by the neurophysiologist. At the end of the patient's participation in the study, these data will be encrypted, anonymized and transmitted to the mathematician to be processed by the PRECOM tool.